Shots:

• The P-III study involves assessing of SB12(600/900 mg- IV) vs Soliris (eculizumab- 600/900 mg- IV) in 50 patients with PNH- evaluating the efficacy- safety- immunogenicity and PK
• The primary outcome of the study is to measure hemolysis by lactate dehydrogenase @26wks. parallel comparison and @52wks. by crossover comparison- with its expected completion in Jul’2021
• SB12 is a biosimilar to Soliris targeted for paroxysmal nocturnal hemoglobinuria. Soliris is mAb- approved by the US FDA for treat atypical hemolytic uremic syndrome- myasthenia gravis and neuromyelitis optica spectrum disorder

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 Ref: Center for Biosimilars| Image: Samsung Bioepis